Wilderness Program for Adolescent and Young Adult Cancer Survivors
NCT ID: NCT04761042
Last Updated: 2021-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-01-01
2023-12-31
Brief Summary
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High quality randomized controlled studies are lacking and thereby urgently needed to investigate the impact of wilderness programs on mental and physical health of adolescent and young adult cancer survivors. The primary aim of this study is to conduct a pilot randomized controlled trial (RCT) on a wilderness program versus an attention-control activity in adolescent and young adult cancer survivors. We will examine the feasibility of performing a RCT and examine health outcomes, in preparation for a larger RCT with adolescent and young adult cancer survivors.
A total of 40 adolescent and young adult cancer survivors (aged 16-39) will be randomized to a wilderness intervention or an attention-control group. The wilderness intervention is a one-week outdoor program where participants have individualized and group activities such as climbing, hiking, kayaking, bush crafting and mindfulness. After this week, participants continue a 3-month program to incorporate elements of the intervention into their daily life. The control group will join a relaxing one-week holiday at a Wellness Center and will be followed for 3 months to control for attention. Study outcomes will be recruitment speed, willingness to be randomized, study adherence, self-reported mental health using validated scales, and tests of physical activity and health (six-minute walk test, submaximal oxygen uptake, blood pressure, sedentary behaviour and physical activity). Outcomes are measured at the start of the study, 1 week and 3 months after intervention. One year follow up of self-reported outcomes will be online. Findings of the study will provide important insights into the feasibility of a large study as well as on ways by which wilderness therapy can promote health in young cancer survivors.
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Detailed Description
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It is hypothesized that the wilderness program is a highly appreciated and safe health promotion intervention that may substantially benefit adolescent and young adult cancer survivors, and that results of the proposed pilot study warrant further research with adequate power to test for effectiveness in a larger RCT.
RCT - Intake (Contact 1)
Young cancer survivors who are interested in participating will contact the researchers of this study at Mid Sweden University via email or phone. The researchers will provide information about the study, both verbally and written in an information letter to be sent by post or email. The following tasks will be carried out at the intake interview:
* Screening of inclusion and exclusion criteria,
* Explanation/information about the study and informed consent procedures,
* Explanation/information about the interventions and the randomisation procedure,
* Check participants' willingness to be randomized, ask if they have a strong preference for either intervention, and ask about their expectations of the interventions,
* Sending the information letter and informed consent forms, including a postage-paid return envelope.
Randomisation (Contact 2)
Written informed consent from the participants will be obtained prior to randomisation. One of the researchers of this study will also sign the informed consent form. After the signed informed consent form has been received, young cancer survivors will be randomised for participation in the study. All data of each randomized participant in the study will be documented in a Case Report Form (CRF) that will be developed for this study. Participants will be contacted by telephone and the following tasks will be carried out:
* Inform participants about the outcome of the randomisation procedure,
* Collect demographic data (DD), medical history (MH), medication use (MU), concomitant medication/therapies, dietary and lifestyle measures,
* Instructions for using the step counter, one week before the start of intervention: All participants that are randomized in the study will be send a step counter, to be used in the week before the intervention,
* Sending the step counter and instructions for use to participants,
* Instruction for measurements and timelines during the study.
Intervention (Visit 1) All participants will travel for the intervention (8 days in total) to Sundsvall, Sweden. At Day 1 of the intervention (Baseline, T=0), participants will perform physical performance/fitness tests at Mid Sweden University under supervision of a test leader from the Sweden Winter Sports Research Centre (Östersund, Sweden). After the tests, participants in the intervention group will be transported to the wilderness site at Höga Kusten, Västernorrland, Sweden. Participants will be provided with outdoor clothes, backpack, tent, sleeping pads and sleeping bag. All other necessary outdoor equipment will be made available through the facilitators. Participants in the control group will be transported to a Wellness Center in Västernorrland. Before leaving for home, a plan for activities in the three-month home program will be discussed with participants in the wilderness program group.
Three-months at home (Contact 3 and 4)
Participants in both groups will be followed during a 3-month period after the one-week intervention. During this period, participants will be contacted by a facilitator via telephone or other media after one month (Contact 3) and two months (Contact 4). The following tasks will be carried out:
* Documentation of concomitant medication/therapy use, dietary and lifestyle measures,
* Documentation of adverse events that may have occurred,
* Filling in the IPAQ,
* Results of the step counter during the week before Contact 3 and 4,
* Adherence and transference of participants to the agreed and planned activities at home (wilderness program group only).
Intervention (Visit 2; Re-visit) After three months, participants will return to Mid Sweden University for follow up measures (T=2), as well as for two additional nights outdoor at Höga Kusten to re-connect (intervention group) or two holiday nights at the Wellness canter (Control group).
One year follow-up One year after start of the intervention (T=3), participants in both groups will be contacted to fill in online self-reported questionnaires. Concomitant medications/therapies, dietary and lifestyle measures will be documented as well as a recent one-week measurement of step counts.
Sample size No sample size calculation is needed for a pilot RCT.
Randomization Participants will be randomized according to a randomization list as generated by the Random Allocation Software Program using a random block size of 2 in order to guarantee a balanced allocation. The two interventions (wilderness therapy versus attention-control are assigned to intervention A and intervention B and upon intake participants will receive a screening number ranging from 01 to 100. Participants who drop out of the study before being randomized will keep their screening number without receiving an intervention. On enrolment in the study, participants that are randomized receive an intervention number (01-110). The study numbers are sequentially allocated to the participants in the order of inclusion in the randomized intervention period. Each participant will receive only that intervention which is labeled with the study number allocated to him/her. Participants will be stratified according to age group (16-22 and 23-30 and 31-39) and gender (male/female) in order to achieve equal distribution among the two groups. Per stratification, separate randomization lists will be generated.
Statistics Regular descriptive statistics will be calculated with regard to demographical and categorical data and mean scores and standard deviations of the numerical variables will be calculated using SPSS (version 25.0). As a first step, preliminary mean differences between, and within groups (over time changes) will be calculated using students t-test, related samples t-test, and R-ANOVA analysis. As a second step, the Aickin separation test will be applied to the domains of the MMQL and other outcome measures to determine whether there are indications of differences, even if obtained p-values are non-significant. If indications of differences are identified with the Aickin separation test it provides information whether a further larger RCT is warranted. The Aickin separation test is used for early phase trials to determine whether the data are 1) in the hypothesized direction, 2) counter to the hypothesized direction or 3) equivocal. Results in the hypothesized direction warrant further research with adequate power to test for effectiveness.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
After being notified of groups assignment the primary investigator again contacts participants to enter the into the study and give information on group assignment.
Outcome data will be entered confidential, and the outcomes assessor will be blinded regarding group assignment and identification of participants.
Study Groups
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Wilderness program
A one-week (8 days) wilderness program, 3-month online support, and a follow-up visit for four days.
WAYA-Wilderness
The wilderness intervention includes challenging tasks in order to help participants' overcome and master new physical and psychological challenges in an unknown environment, with the idea to support self-efficacy, self-esteem, and ability to recover from adversity. The program is designed to encourage participants to connect with nature as to experience gratitude for the richness of the natural world, a sense of calmness and trust upon spending time in nature, and to be more physically active in nature.
Elements previously described Participants will continue in a three-month program at home (on-line supported) after the initial 8-days in order to empower participants to incorporate elements of the onsite wilderness program into their daily life. An individualized a plan for activities will be developed together with the participant.
After three months, there will be a re-visit with follow up on outcome measures and reconnection.
Holiday program (Attention control)
A one-week (8 days) holiday program, 3-month online contact, and a follow-up visit for four days.
WAYA-Holiday
An attention control group (information in "Detailed description")
Interventions
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WAYA-Wilderness
The wilderness intervention includes challenging tasks in order to help participants' overcome and master new physical and psychological challenges in an unknown environment, with the idea to support self-efficacy, self-esteem, and ability to recover from adversity. The program is designed to encourage participants to connect with nature as to experience gratitude for the richness of the natural world, a sense of calmness and trust upon spending time in nature, and to be more physically active in nature.
Elements previously described Participants will continue in a three-month program at home (on-line supported) after the initial 8-days in order to empower participants to incorporate elements of the onsite wilderness program into their daily life. An individualized a plan for activities will be developed together with the participant.
After three months, there will be a re-visit with follow up on outcome measures and reconnection.
WAYA-Holiday
An attention control group (information in "Detailed description")
Eligibility Criteria
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Inclusion Criteria
* any sex,
* aged 16-39,
* diagnosed with any type of cancer during their course of living
* can be reached by telephone,
* have good understanding of the Swedish language.
* ability to walk 2 km without pausing (walking aids permitted).
Participants with various medical conditions, including mobility impairments, amputees, vision impairments and special treatment or diet needs will be included. No prior experience with any outdoor activity is required.
Exclusion Criteria
* other medical conditions that prevent safe travel to, or participation in the program
16 Years
39 Years
ALL
No
Sponsors
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UiT The Arctic University of Norway
OTHER
University of California, San Francisco
OTHER
See You At The Summit
UNKNOWN
Sörlandet Hospital, Norway
UNKNOWN
The Swedish Winter Sports Research Centre
UNKNOWN
Mid Sweden University
OTHER
Responsible Party
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Principal Investigators
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Mats Jong, PhD
Role: PRINCIPAL_INVESTIGATOR
Dep of Health Sciences/Public Health, Mid Sweden University, Sundsvall, Sweden
Locations
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Mid Sweden University, department of Health Sciences
Sundsvall, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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Jong MC, Dahlqvist H, Lown EA, Schats W, Beckman L, Jong M. A randomized controlled pilot study assessing feasibility and safety of a wilderness program for childhood, adolescent, and young adult cancer survivors: the WAYA study. BMC Public Health. 2023 Aug 8;23(1):1504. doi: 10.1186/s12889-023-16408-x.
Jong MC, Mulder E, Kristoffersen AE, Stub T, Dahlqvist H, Viitasara E, Lown EA, Schats W, Jong M. Protocol of a mixed-method randomised controlled pilot study evaluating a wilderness programme for adolescent and young adult cancer survivors: the WAYA study. BMJ Open. 2022 May 9;12(5):e061502. doi: 10.1136/bmjopen-2022-061502.
Other Identifiers
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Dnr 2019-67
Identifier Type: -
Identifier Source: org_study_id
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